Chamber, patient, hyperbaric (Cancelled from the ARTG under s.41GN(1)(b))
Product name
Chamber, patient, hyperbaric
Sponsor
ARTG
204982
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b)
Grounds for regulatory action
As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a).